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External Locking Plate CLP-01Recalls & reported problems

Elevation Spine, Inc. · Saber-C Locking Plate · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810017910069), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Inadequate Osseointegration1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE PATIENT'S ORIGINAL OPERATION OCCURRED ON (B)(6) 2024. IN A POST OP FOLLOW-UP, IMAGING SHOWED WHAT APPEARED TO BE THE LOCKING PLATE DISASSOCIATED FROM ITS INITIAL LOCKED POSITION ON TWO SABER-C SPACERS, AND THE SPIKES APPEARED TO BE MIGRATING OUT OF THE SPACER IMPLANT. A REVISION SURGERY OCCURRED ON (B)(6) 2024 IN WHICH THE IMPLANTED SABER-C LOCKING PLATES AND SPIKE IMPLANTS WERE REMOVED FROM BOTH THE IMPLANTED SPACERS, BUT THE SPACERS THEMSELVES WERE LEFT IMPLANTED. SABER-C SYSTEM BONE SCREWS WERE THEN USED TO FIXATE THE SPACERS IN PLACE AND NEW LOCKING PLATES WERE USED TO COMPLETE THE PROCEDURE.

    Patient problems: Inadequate Osseointegration

    MAUDE report 20321081 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.